UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031779 |
|---|---|
| Receipt number | R000036265 |
| Scientific Title | attempt to develop a new family-assessment by means of realtime biological indices |
| Date of disclosure of the study information | 2018/03/18 |
| Last modified on | 2018/03/18 11:12:39 |
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Basic information
Public title
attempt to develop a new family-assessment by means of realtime biological indices
Acronym
a family-assessment by biological indices
Scientific Title
attempt to develop a new family-assessment by means of realtime biological indices
Scientific Title:Acronym
a family-assessment by biological indices
Region
| Japan |
Condition
Condition
social anxiety disorder, adjustment disorder, eating disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of realtime biological indices for family-assessment at the begining of family therapy for mental disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
some psychological examinations (e.g. Family Assessment Device Profile of Mood States)
directly before family therapy and six months after the begining of family therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Seven family therapy sessions of 60 minites will be conducted every 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who are diagnosed as social anxiety disorder, adjustment disorder or eating disorder by DMS-5 and recommended family therapy by their psychiatrists in charge, and whose both parents can attend each session of family therapy
Key exclusion criteria
Exclusion criteria are not established.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko MURAMATSU |
Organization
Kyoto Notre Dame University
Division name
Department of Psychology
Zip code
Address
1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL
075-706-3680
Muratomo@notredame.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko MURAMATSU |
Organization
Kyoto Notre Dame University
Division name
Department of Psychology
Zip code
Address
1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL
075-706-3680
Homepage URL
Muratomo@notredame.ac.jp
Sponsor or person
Institute
Department of Psychology, Kyoto Notre Dame University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Kyoto Notre Dame University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Grants-in-Aid for Scientific Research
Other related organizations
Co-sponsor
Iwakura Hospital
Name of secondary funder(s)
Kyoto University
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036265
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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